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510(k) K801619

MIST2GEN TEMPTROL 10 by Mistogen Equipment Co. — Product Code BTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1980
Date Received
July 15, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5450
Review Panel
AN
Submission Type

Other clearances by Mistogen Equipment Co.

  • K781591 — NEBULIZER/HUMIDIFIER MODEL EH 147B (October 16, 1978)
  • K770984 — TA-2 TEMPERATURE ALARM (July 5, 1977)
  • K760341 — HUMIDIFIER, ELECTRONIC (EH147) (August 11, 1976)

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